UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Title of the study (Brief title)	Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Region	Japan

Condition
Condition	congenital heart disease
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of maternally targeted nursing interventions in improving the self-care of infants and schoolchildren with congenital heart disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the perceptions of parent
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	We provided nursing interventions for a patient's parent: before surgery and before discharge from hospital.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a parent whose children were scheduled for surgery for cyanotic congenital heart disease and who met all of the following criteria were included: 1. willing to explain the treatment and recuperation activities to their children and to have the children do what they could by themselves 2. able to read and write Japanese 3. children aged between 2 years 10 months and 9 years 4. children needing long-term postoperative self-care 5. children able to communicate with others
Key exclusion criteria	a parent whose children had undergone emergency surgery
Target sample size	6

Research contact person
Name of lead principal investigator	Hiromi Handa / Keiko Ninomiya
Organization	Kobe City College of Nursing
Division name	Doctoral Program
Address	3-4 Gakuennisimachi,Nisiku, Kobe city, Hyogo, Japan
TEL	078-794-8080
Email	d1404@st.kobe-ccn.ac.jp

Public contact
Name of contact person	Hiromi Handa
Organization	Okayama University Hospital
Division name	Nursing Department
Address	2-5-1 Sikatacho, Kitaku, Okayama city, Okayama
TEL	086-223-7151
Homepage URL
Email	handa-h1@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 15 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 14 Day
Last modified on	2018 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026963